Device product
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room
Z-0140-2017
Product summary
- Event
- Event 71968
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 kits
- Official record key
device-enforcement:Z-0140-2017
Official wording
Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.
Code information: Lot Numbers/Expiration Dates: 62789 11/7/2015 61201 11/8/2015 63413 11/9/2015 67096 11/9/2015 64598 1/29/2016 74803 6/26/2016 57510 6/27/2016 67607 8/21/2016 69801 9/15/2016 71002 10/6/2016 68446 10/9/2016 71403 12/24/2016 72095 1/14/2017 78759 11/5/2017 81077 2/13/2018
Distribution pattern: Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Derived failure modes
-
Unknown
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.